A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab) in Patients With Moderately to Severely Active Crohn's Disease



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:2/14/2019
Start Date:September 16, 2015
End Date:November 8, 2022

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An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

This is an open label, single group, long term safety extension trial to provide a long-term
treatment option for subjects who responded to treatment with BI 655066/ABBV-066
(risankizumab) in a preceding trial.


Inclusion Criteria:

- Patients with Crohn`s disease, who have successfully completed the preceding trial
1311.6. Successful treatment is defined as:

1. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's
Disease Activity Index from baseline by >/=100) but no remission (Crohn's Disease
Activity Index < 150) at Visit E1; or

2. Completion of period 3 in 1311.6 with a clinical response (drop in Crohn's
Disease Activity Index from baseline by >/=100) and/or remission (Crohn's Disease
Activity Index < 150) at Visit E5; or

3. Completion of period 2 or 3 in 1311.6 per protocol with a clinical response or
remission before initiation of 1311.20/M15989 may roll-over either directly if
that response/remission is maintained or through an open-label i.v. re-induction
phase if they have lost their previous response/remission.

- Female patients:

1. Women of childbearing potential (not surgically sterilized and between menarche
and 1 year postmenopause), that, if sexually active agree to use one of the
appropriate medically accepted methods of birth control in addition to the
consistent and correct use of a condom from date of screening until 20 weeks
after last administration of study medication. Medically accepted methods of
contraception are: ethinyl estradiol containing contraceptives, diaphragm with
spermicide substance, and intra-uterine-device, or

2. Surgically sterilized female patients with documentation of prior hysterectomy,
tubal ligation or complete bilateral oophorectomy, or

3. Postmenopausal women with postmenopausal is defined as permanent cessation >/=1
year of previously occurring menses, and

4. Negative serum ß-Human Chorionic Gonadotrophin test at screening and urine
pregnancy test prior to randomization.

- Male patients:

1. Who are documented to be sterile, or

2. Who consistently and correctly use effective method of contraception (i.e.
condoms) during the study and 20 weeks after last administration of study
medication.

- Be able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

- Patients who were not compliant with key study procedures (colonoscopy, treatment
compliance, endpoint assessment, contraception measures) in preceding trial 1311.6

- Patients who could not tolerate BI 655066/ABBV-066 (Risankizumab) treatment for
tolerability or safety reasons in the preceding trial

- Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 20
weeks after receiving the last dose of study medication.

- Patients must agree not to receive a live virus or bacterial or Bacille
Calmette-Guérin vaccination during the study or up to 12 months after the last
administration of study drug.

- Patients who have developed malignancy, or suspicion of active malignant disease
during the preceding trial

- Are intending to participate in any other study using an investigational agent or
procedure during participation in this study.

- Cannot adhere to the concomitant medication requirements
We found this trial at
3
sites
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Chevy Chase, MD
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Chesterfield, Michigan 48047
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Chesterfield, MI
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Woluwe-Saint-Lambert, Bruxelles-Capitale
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mi
from
Woluwe-Saint-Lambert,
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